OWV — Mesh, Surgical, Collagen, Diaphragmatic Hernia Class II
FDA product code OWV covers "Mesh, Surgical, Collagen, Diaphragmatic Hernia", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OWV
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K133011 | cook biotech | DIAPHRAGMATIC HERNIA GRAFT | June 20, 2014 |